Malignant Advanced Solid Tumor Clinical Trial
Official title:
A Safety, Tolerability and Pharmacokinetic Study of Single and Repeat Oral Escalating Doses of Simmiparib in Patients With Advanced Malignant Tumors
Phase I dose escalating trial. Primary objectives of this study are to assess the safety and
tolerability of Simmiparib following single and multiple oral doses in patients with
advanced solid malignancies, to determine the maximum tolerance dose (MTD) and dose limiting
toxicity (DLT), and pharmacokinetic profile.
The Secondary objective is to observe the preliminary antitumor effect of Simmiparib.
This single-center, nonrandomized, open-label, dose-escalating study. The trial was divided into dose escalation and expansion stages. ;
Intervention Model: Single Group Assignment, Masking: Open Label